search
Back to results

Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise: local high intensity interval exercise
Exercise: best clinical practice
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Shoulder, Exercise therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • shoulder pain for longer than three months
  • clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test)
  • normal passive range of motion of the shoulder

Exclusion Criteria:

  • subjects unable to provide an informed consent
  • lack of ability to complete the intervention
  • full rupture of the tendon of m. supraspinatus
  • planned shoulder surgery, or previous shoulder surgery on affected shoulder
  • other musculoskeletal problem that could explain the symptoms
  • adhesive capsulitis
  • pregnancy
  • rheumatoid arthritis
  • symptomatic osteoarthritis of the shoulder/shoulder girdle
  • glenohumeral instability
  • widespread pain syndrome
  • unstable underlying heart disease
  • cortisone injections in the shoulder the last month
  • allergies
  • other serious mental or somatic disease (i.e. psychosis or active cancer disease).

Sites / Locations

  • St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.

The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).

Outcomes

Primary Outcome Measures

Time to exhaustion, incremental test
participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.

Secondary Outcome Measures

SPADI questionnaire
Subjective pain and function outcomes (Likert scales)
SPADI questionnaire
Subjective pain and function outcomes (Likert scales)
Weight
Weight (kg)
Height
Height (cm)
Age
Age (years)
Duration of symptoms
Duration of symptoms (months)
Affected shoulder
What shoulder is affected (left/right)
Socioeconomic status
The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation
1 repetition maximum (1RM), bilateral shoulder test
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
1 repetition maximum (1RM), bilateral shoulder test
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Time to exhaustion, steady state
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Time to exhaustion, steady state
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.

Full Information

First Posted
February 25, 2016
Last Updated
March 20, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02701465
Brief Title
Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
Official Title
Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Shoulder, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).
Intervention Type
Other
Intervention Name(s)
Exercise: local high intensity interval exercise
Intervention Description
The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.
Intervention Type
Other
Intervention Name(s)
Exercise: best clinical practice
Intervention Description
The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).
Primary Outcome Measure Information:
Title
Time to exhaustion, incremental test
Description
participants abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. Every minute the load is increased with 250 grams. The test is stopped if participant fails to maintain pace or movement quality, or experiences increased pain. Time at failure is noted as the result.
Time Frame
Week 0
Secondary Outcome Measure Information:
Title
SPADI questionnaire
Description
Subjective pain and function outcomes (Likert scales)
Time Frame
Week 0
Title
SPADI questionnaire
Description
Subjective pain and function outcomes (Likert scales)
Time Frame
Pre+post-test (8 weeks in-between)
Title
Weight
Description
Weight (kg)
Time Frame
Week 0
Title
Height
Description
Height (cm)
Time Frame
Week 0
Title
Age
Description
Age (years)
Time Frame
Week 0
Title
Duration of symptoms
Description
Duration of symptoms (months)
Time Frame
Week 0
Title
Affected shoulder
Description
What shoulder is affected (left/right)
Time Frame
Week 0
Title
Socioeconomic status
Description
The patient fills in a questionnaire stating number of children, marital status, welfare status and working situation
Time Frame
Week 0
Title
1 repetition maximum (1RM), bilateral shoulder test
Description
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Time Frame
Week 0
Title
1 repetition maximum (1RM), bilateral shoulder test
Description
After warmup: maximal strength was measured as the weight the subject could manage to lift once - usually achieved in 3-5 attempts. The movement conducted was the earlier described scapularization movement.
Time Frame
Week 8
Title
Time to exhaustion, steady state
Description
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Time Frame
Week 0
Title
Time to exhaustion, steady state
Description
Subject abduct their shoulder up to 90 degrees in scapula's plane (scapularization) at a frequency of 0,5 Hz. The load is set to 80% of the incremental time to exhaustion test. The test is stopped if the fails to maintain pace or movement quality, or the subject experience increased pain. Time at failure is noted as the result.
Time Frame
Week 8
Title
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Description
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Time Frame
Week 0
Title
Regional blood flow in m. supraspinatus, using contrast enhanced ultrasound (concentration of white analyzed as decibels in region of interest)
Description
Baseline images will be taken with ultrasonic device to confirm an intact m. supraspinatus. An intravenous line will be inserted in the contralateral arm and the patient will be injected with a bolus of contrast dye (Optison, 3 ml bolus, 0.19 mg / mL perflutren). The injection is administered by a physician related to the research project. Measurements of regional blood flow at rest made are of the supraspinatus tendon. Then the participants perform a standardized training exercise to recruit the vasculature in m. supraspinatus (scapularization to 90 degrees, 80% of TTU weight (incremental), 3 minutes). Post-exercise images are taken immediately after this.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: shoulder pain for longer than three months clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test) normal passive range of motion of the shoulder Exclusion Criteria: subjects unable to provide an informed consent lack of ability to complete the intervention full rupture of the tendon of m. supraspinatus planned shoulder surgery, or previous shoulder surgery on affected shoulder other musculoskeletal problem that could explain the symptoms adhesive capsulitis pregnancy rheumatoid arthritis symptomatic osteoarthritis of the shoulder/shoulder girdle glenohumeral instability widespread pain syndrome unstable underlying heart disease cortisone injections in the shoulder the last month allergies other serious mental or somatic disease (i.e. psychosis or active cancer disease).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hoff, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital, back-neck-shoulder multidiciplinary clinic
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

We'll reach out to this number within 24 hrs